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Showing 1-20 of 35 trials
NCT06614582
This research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea.
NCT05974488
The purpose of this study is to investigate the effect of using the McMurray Enhanced Airway (MEA) which is a flexible extended-length distal pharyngeal airway on improving oxygen delivery compared to standard nasal cannula.
NCT04549545
The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).
NCT05880836
The objective of ILAN is to assess the safety, feasibility and bronchodilator efficacy of in-line bronchodilator nebulizer delivery with VMN via HFNC system in hypoxemic respiratory failure patients treated with bronchodilators and compare this method to standard-nebulization using a jet nebulizer with a facial mask. The investigators hypothesized that aerosol nebulization using HFNC/VMN represents safer and more convenient approach in hypoxemic respiratory failure patients in comparison to conventional therapy while providing similar bronchodilator efficacy.
NCT06545903
The aim of this clinical trial is to evaluate four supraglottic airway devices for ventilation in a simulated condition of an entrapped trauma patient with simultaneous cervical spine immobilisation. All the studied devices are evaluated by fully-qualified and experienced paramedics (both male and female). The main questions it aims to answer are: 1. Which device requires the shortest time required to achieve a successful ventilation? 2. What is the first attempt success rate of the studied devices? 3. Which device is the easiest to use and the most user-friendly? Study participants will evaluate four different supraglottic devices in a restricted access to the entrapped trauma patient's airway. The maximum number of insertion attempts is limited to three per device.
NCT04907695
The US Military is rapidly transitioning into preparing for multi-domain operations. Previous data demonstrates that the most common airway replaced in the prehospital combat setting is endotracheal intubation. Previous studies have suggested that video laryngoscopy (VL) is superior to direct laryngoscopy (DL), which is most prominently noted in the office users . However, the current durable equipment video laryngoscopes are very expensive and cost prohibitive for dispersion around the battlefield. The i-view is a novel video laryngoscope that is marketed for VL and is inexpensive and disposable. Both the durable VL and the i-view are already in use in our emergency department (ED). The investigators are also already collecting data using these devices as part of an approved protocol for an airway registry. The investigators are seeking to utilizing a clinical rotating protocol to compare these two devices in the emergency department.
NCT04781153
The purpose of this study is to investigate if treatment of periodontitis (gum disease) in a relatively young and healthy population can improve lung function. It is hypothesized that removing the dental biofilm reduce the source of inflammatory bacteria that can reach the lungs, and thereby reduce lung inflammation and lead to improved lung function.
NCT05747014
The Novapak study is a prospective, observational, multi-site, non-controlled, non-randomized, case-series, with a 2 week and 1-month follow-up in adults undergoing nasal/sinus surgery with Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively and is being conducted to obtain clinical data on the safety and effectiveness of the Novapak device under use as intended in the device indications.
NCT05090696
The mechanical in-exsufflator (MI-E) is a medical device used to facilitate coughing when the patients' cough is not efficient. Studies have shown positive results in helping airway clearance in children and adults with neuromuscular disorders however there is lack of evidence in older populations. This study's aim is to evaluate the feasibility of the MI-E in older adults. The hypothesis is that the use of MI-E in older adults is feasible.
NCT05783050
Sedoanalgesia is applied to patients during gastrointestinal endoscopy. Sedoanalgesia may cause respiratory depression and hypoxia in patients. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia.This study aimed to compare the efficacy and procedural performance of two different airway devices (Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support) in Gastrointestinal Endoscopy
NCT06270212
OVERALL SYNOPSIS PART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants * of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype (STAIRWAY) vs. standard procedure (no device) during target-controlled induction of mild and moderate-to-deep sedation with propofol in the supine position * of minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels, determined by magnetic resonance imaging (MRI) with STAIRWAY vs. biteblock or no device during no, mild and moderate-to-deep steady-state sedation with propofol in the supine position. PART B: Systematic evaluation (in the body position \[normally supine\] considered most optimal for the procedural intervention) of the cumulative duration * of adjuvant manual airway support and ventilation * of respiratory arrest (interrupted monitoring of endtidal carbon dioxide \[ETCO2\]) * of hypoxemia (hemoglobin saturation of oxygen \[SpO2\] \<95 %), and * of perceived sedational comfort, of sedational and procedural usability, and of sedational and procedural preference with STAIRWAY vs. standard procedure (biteblock or no device) during PS according to SOC for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in spontaneously breathing study patients.
NCT06069817
The application of HFNC therapy in patients with airway stent, improving both humidification and clearance of the airway secretion, could potentially reduce the risk of mucoid impaction, respiratory infections and granulation. HFNC therapy could be superior to nebulization of normal saline (usual care) in order to keep the stent cleaned, reducing, by inference, the risk of complications, as defined above.
NCT06128811
This randomized clinical trial will aim to evaluate the effect of DryShield isolation (DSI) and Rubber Dam isolation (RDI) systems on arterial oxygen saturation (SpO2), heart rate (HR), blood pressure (BP), behavior, subjective pain and discomfort, and time required among children with different airway patency based on Modified Mallampati classification (MMC). Healthy, cooperative 6-12-year-old children who need fissure sealant in at least two contralateral fully erupted permanent first molars will be included. The airway patency will be determined using MMC by two trained and calibrated dentists. Participants will be categorized based on their MMC score into patent airway (MMC Class I and II) and non-patent airway (MMC Class III and IV). During the treatment, the dental procedure will be videotaped, and the vital signs, including SpO2, HR, and BP, will be recorded every three minutes. A Validated Arabic Version of the Wong-Baker Pain Rating and the Face, Legs, Activity, Cry, Consolability (FLACC) scales will be utilized to record the participants' pain levels. In contrast, Frankl's Behavior will record their behavior during the dental procedure. Following the dental treatment, the participants' subjective pain and discomfort will be evaluated using a previously validated Arabic interview questionnaire.
NCT03455881
The investigators propose a preliminary study performing exome sequencing on samples from patients and their biologically related family members with tracheal and esophageal birth defects (TED). The purpose of this study is to determine if patients diagnosed with TED and similar disorders carry distinct mutations that lead to predisposition. The investigators will use advanced, non-invasive magnetic resonance imaging (MRI) techniques to assess tracheal esophageal, lung, and cardiac morphology and function in Neonatal Intensive Care Unit (NICU) patients. MRI techniques is done exclusively if patient is clinically treated at primary study location and if patient has not yet had their initial esophageal repair.
NCT04244565
Effect of Self-Directed Versus Traditional Clinical Learning Model on Nurses' Airway Management Competencies and Patients' Airway Related Incidents Introduction Airway crisis situations in ICUs (Intensive Care Units) are common, complex, dynamic and time-sensitive contexts, that pose a significant threat to patient safety, and are a major source of preventable errors. Airway management has the highest priority in patient care, it is the first step in the (ABCDE) approach. The concept of Airway management in nursing perspective includes any nursing procedures and techniques required to keep the airway open and prevent aspiration. Adult learning is a practice in which adults engage in systematic and sustained learning activities in order to gain new forms of knowledge, skills or values. Most adult education is voluntary; therefore, the participants are generally self-motivated. Continuing education (CE) of nurses is increasingly necessary to keep abreast of rapid changes in patient care due to advancements in knowledge and technology and improve their ability to serve the patients safely. Although nursing care has been changed significantly over the past 30 years, methods for clinical training nurses have not. A popular or traditional model for clinical teaching of nurses, including but not limited to; integrating lectures, skills laboratory training and supervised clinical experience. A benefit of this model is the opportunity to assist nurses to integrate the concept learned in class or skill lab in patient care. Also, the instructor can select clinical activities that best meet nurses' needs and are consistent with hospital goals. While, Self-directed learning (SDL) is one of modern approaches of clinical learning, the concept of SDL originates from the Adult Learning Theory, it is a process in which the instructors play a facilitating role while, learners actively participate in identifying their own learning needs, learning goals, allocating resources \& decide whether learning method can be used, and engaging in self-reflection \& evaluation. The positive outcomes of SDL including but not limited to, greater self-control, self-confidence, autonomy, and lifelong learning skills. In essence the aim of this study will be examining the effect of Self-directed clinical learning model as compared to the traditional models to improve nurses' Airway management competencies and minimize airway related incidents. Research Hypothesis H1: Critically care nurses who will approach self-directed clinical learning model (μ1) will have a higher level of Airway management skills (μ2), (H1: μ1 \> μ2). H1: Intensive care units who will approach self-directed clinical learning model to learn their working nurses (μ1) will have a lower frequency of patients' airway-related incidents (μ2), (H1: μ1 \< μ2). Subjects and Methods True experimental, prospective, and comparative research design will be utilized in the current study. This study will be conducted at selected two Adult Intensive Care Units, A convenience sample of 60 male and female Critically Care Nurses who are working in the selected Intensive Care Unit, will be recruited to the study. The sample size estimated by (G Power analysis) (independent t tests - One tail, Effect size = 0.65, α = 0.05, Power (1-β) = 0.80, balanced allocation ratio 1:1). The total sample size will be divided into two groups (study and control). All nurses should be corresponded to specific inclusion criteria. Five tools will be formulated to collect data pertinent to the study. Procedure The study will be conducted through three phases; preparation \& designation, implementation, and follow up \& evaluation phase. The 1st Part will be initiated by allocating the selected ICUs randomly into two paired settings, one for applying traditional learning (control ICU) and the other for self-directed learning experimentation (study ICU). the nurses who are working in selected ICUs and correspond to the inclusion criteria, will be randomly distributed into two equal groups (30 nurses in each group). The nurses who are working in study ICU will be asked to fill out the nurses' readiness assessment sheet to learn independently. The nurses who will demonstrate a high readiness score (\>80%) for independent learning will be included. Once implantation is complete, the follow-up and evaluation phase will be initiated by daily monitoring of the occurrence of patients' airway related incidents in both control and study ICUs for a continuous three months. Then, the nurses' knowledge and practices (in the control group) will be evaluated two times, 1st time will be 1 month after the implementation phase, and the second time will be after 3 months from the 1st evaluation (to measure the retention of given education and training). Upon completion of data collection, descriptive and inferential statistics will be utilized to test for differences among the study and control group subjects.
NCT05708651
The goal of this four-part preclinical \[I-II\] and clinical \[III-IV\] trial is to compare, with randomised crossover study design \[I-IV\], a new medical airway device with standard procedure (biteblock or no device) for upper airway patency during sedation with intravenous propofol \[I-IV\]. \- Page 1 of 9 \[DRAFT\] - The two main questions it aims to answer are if this new airway device is superior to standard procedure with respect to * maintenance of spontaneous ventilation \[I\] and upper airway volumes \[II\] at moderate and deep steady-state levels of sedation in healthy volunteer study participants, and * fewer and less lasting bedside signs of respiratory depression \[III-IV\], and less adjuvant use of manual airway support \[III-IV\] during procedural sedation (PS) according to standard of care(SOC) in study patients scheduled for colonoscopy or ureteral catheterisation under PS. Owing to the crossover study design used throughout the trial, there are no comparison groups of study participants \[I-II\] or study patients \[III-IV\].
NCT04730362
This study compare the effects of Oral airway vs LMA in preventing anesthesia-induced partial airway obstruction, in an attempt to lessen MRI motion artifacts, which would result in improvements in image quality.
NCT03144089
The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The investigators hypothesize that, in patients with predictors for difficult mask ventilation, the AOA will be non-inferior to the Geudel oral airway in terms of expired tidal volumes.
NCT02317042
This study is to evaluate the efficacy of a new therapy (Automatic Expiratory Positive Airway Pressure with intelligent Volume Assured Pressure Support (AutoEPAP iVAPS)) designed to treat respiratory insufficiency, respiratory failure and/or nocturnal hypoventilation with upper airway obstruction. The study will be performed in two phases: In a sleep unit and in the home environment. The new therapy will be compared against two existing ventilator therapies: "Spontaneous Timed (ST) mode" and "Intelligent Volume Assured Pressure Support (iVAPS)".
NCT04419883
The purpose of this prospective pilot provider adoption study was to evaluate user experience a new airway device in adult patients with airway obstruction under deep sedation. Fifteen hospital systems served as testing sites. Fifty-four anaesthetist providers reported their experience with the airway device in 84 cases across two phases of surveying.